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DERMATOME, ELECTRICAL (ACCULAN 4) with battery + access.

https://unicat.msf.org/cat/product/78496
STD EEMDDERE6--

Valid Article

CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
Z120103 - Dermotomy equipment
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
M
The order of this product needs to be justified and is only acceptable under certain conditions.
UN3481
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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DERMATOME, ELECTRICAL (ACCULAN 4)

Definition

Acculan 4 is the battery-operated power system for orthopaedics, traumatology, cardiothoracic surgery and dermatology.

A battery-powered surgical instrument designed to cut from the body (harvest) thin donor slices of skin for skin grafting, or to excise small skin lesions, using a dedicated insertable blade. A rechargeable battery pack is connected to the instrument to provide the electrical power for operation. This is a reusable device.

The Acculan 4 is replacing the 3Ti which is no longer produced. Nearly all accessories and spare-parts are compatible between the two models (except the charger for batteries)

Specifications

The dermatome combined with dermatome blade, is used for split skin removal in adjustable depth.

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Technical specifications

  • Blade travel: 3.1 mm
  • 6500 strokes/min maximum
  • Size of cut:
    • 78 mm width maximum
    • adjustable with 10 flaps of 8 mm wide
  • Thickness of cut:
    • 0.2 mm to 1.2 mm
    • graduation every 0.1 mm
  • Dimensions: 277 x 113 x 83 mm
  • Weight: (operational): 1.65kg (+/- 10%)
  • Autoclavable at 134ºC (= 2 bars) or 121ºC (= 1 bar)
  • Battery powered: replaceable Li-ion battery <100Wh
  • Protection against electric shock
    • Type BF

Packaging & Labelling

  • Dermatome + accessories: unit packaging.
  • Blades: unit sterile packaging (box of 10)

(Cf Introduction: Packaging and labelling)

Transport Dangerous Goods

  • UN3481 Lithium ion batteries contained in equipment
  • Class: 9
  • Packing Instructions: 967 Section II
  • The label must include the UN code of the battery + an emergency number to contact in case of an incident
  • Limit per package:
    • Pax A/C (Passengers & Cargo Aircraft) = 5 kg
    • CAO (Cargo Aircraft Only) = 5 kg
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Supplied with the Article

  • 1 coverGA675
  • 1 sterile funnel (included with dermatome GA678)
  • 1 rechargeable battery (Li-ION) GA666
  • 1 battery charger GA320
  • 1 power cord Europe TE730
  • 1 storage tray JB254R
  • 1 fixation for lid GB487R
  • 1 fixation for funnel GB488R
  • 30 single use, sterile blades: 3 x GB228R

Instructions for use

Read the instructions manual carefully.

Precautions for Use

To avoid damaging the device through improper assembly/operation and losing the manufacturer's warranty:

  • Use the device only according to the instructions for use
  • Follow safety and maintenance instructions

Maintenance

The dermatome must be cleaned and sterilized by steam autoclave after each use. Remove the rechargeable battery and dismantle the components with great care, without forcing. Do not sterilise the rechargeable battery.

(Cf Introduction: Disinfection and sterilization in the field)

Waste management

Immediately after use, dispose of the blade into a sharps container

(Cf Public Health Engineering In Precarious Situations, MSF, 2010, Chapter 6)

MSF requirements

Alternative to the manual dermatome (see related articles)

Recommended for use in projects with a high volume of skin grafting including those with high numbers of burns patients, specialised trauma projects, and reconstructive surgery projects.

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